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Does Bicarbonate in Addition to Theophylline Reduce CIN?

NCT02643602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2016-01-01

No results posted yet for this study

Summary

Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.

Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.

Conditions

  • Radiographic Contrast Agent Nephropathy

Interventions

OTHER

Hydration with bicarbonate in addition to theophylline

0.154-molar sodium bicarbonate; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours

OTHER

Hydration with sodium chloride in addition to theophylline

0.9% sodium chloride; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Wolfgang Huber, M.D. · 2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2012-06-30
Completion
2012-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643602 on ClinicalTrials.gov